BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ENDO POCKET BAG 3X4

    MDR report key: 7028846 · Received November 14, 2017

    Report

    Report Number
    3007216334-2017-00244
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Date of Event
    October 16, 2017
    Report Date
    November 14, 2017
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR NARRATIVE. THE MANUFACTURER UNIMAX MEDICAL SYSTEMS, INC. IS RESPONSIBLE FOR PERFORMING EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE PER AGREEMENT WITH CONMED CORPORATION.

    Description of Event or Problem · 1

    A CONMED REPRESENTATIVE REPORTED ON BEHALF OF A USER FACILITY THAT A SB534 MINI ENDO POCKET BROKE DURING AN ECTOPIC PROCEDURE. TO DATE, ALTHOUGH MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION, INFORMATION REGARDING PATIENT STATUS AND EVENT INFORMATION HAVE NOT BEEN PROVIDED. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806548 MINI ENDO POCKET BAG 3X4 SPECIMEN BAGS GCJ UNIMAX MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1